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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

All eligible patients were randomized to one of the 2 arms in a 1:1 ratio for 26 weeks of treatment.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

A total of 523 patients were randomized. A total of 522 patients (99.8%) were included in the Full analysis Set (FAS) and Safety set. One patient was excluded who was randomized in error and did not receive study medication.

Reporting Groups

Description

QVA149

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Fluticasone/Salmeterol

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

QVA149

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Fluticasone/Salmeterol

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.

0 is the minimum score = “none” or “No symptoms” or “never” or “No”

= mild, a little

= moderate

= severe For the scale range provided, high values represent a worse outcome.

Time Frame

12 weeks and 26 weeks

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups

Description

QVA149

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Fluticasone/Salmeterol

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values

QVA149

Fluticasone/Salmeterol

Participants Analyzed [Units: Participants]

253

259

Change From Baseline in Symptom Scores Reported Using the Ediary [Units: Units on a scale]Least Squares Mean (Standard Error)

Weeks 1-12

-1.08 (0.135)

-1.17 (0.133)

Weeks 1-26

-1.28 (0.140)

-1.24 (0.138)

No statistical analysis provided for Change From Baseline in Symptom Scores Reported Using the Ediary